Stereotactic Radiation in Patients With Small Cell Lung Cancer and 1-10 Brain Metastases

N/AActive Not RecruitingNCT03391362

Brigham and Women's Hospital100 enrolled

Overview

This research study is studying stereotactic radiation (focused/pinpoint radiation that targets each individual tumor but not the surrounding brain) instead of whole-brain radiation (radiation targeting the entire brain) as a possible treatment for patients with small cell lung cancer and 1-10 brain metastases. The intervention involved in this study is: -Stereotactic (focused, pinpoint) radiation

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational treatment, in this case stereotactic radiation, to learn whether this treatment works in treating a specific disease. "Investigational" means that the treatment is being studied. In patients with a limited number of brain metastases (spread of a cancer that started outside of the brain to the brain itself) the standard radiation option is stereotactic radiation, which involves using a high dose of radiation that only targets the specific metastases that are visible on imaging of the brain, not the whole brain itself. However, studies evaluating the role of stereotactic radiation to treat brain metastases generally excluded patients with small cell lung cancer. Therefore, among patients with small cell lung cancer and brain metastases, the typical treatment that has been offered is whole brain radiation. However, whole brain radiation has deleterious associated side effects including significant fatigue and permanent memory/attention problems. The investigators are studying whether stereotactic radiation can be effectively utilized for patients with small cell lung cancer and brain metastases in order to avoid such side effects.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Brain Metastases Small Cell Lung Cancer

Interventions

Stereotactic RadiationRADIATION

Stereotactic radiation involves using a high dose of radiation that only targets the specific metastases

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants must have a biopsy-proven tumor consistent with small cell lung cancer and intracranial lesions radiographically consistent with or pathologically proven to be brain metastases. Patients who have undergone prior systemic therapy are eligible. Patients who have undergone resection of one or more brain metastases but who have not yet started adjuvant radiotherapy are eligible for the study. * 1-10 definitive intracranial lesions must be present on MRI of the brain. * Age \>=18 years at diagnosis of brain metastases. Exclusion Criteria: * Participants who have undergone prior radiation for brain metastases. * Participants who have received prophylactic cranial radiation for prevention of brain metastases * Participants who cannot receive gadolinium * Participants with stage IV-V chronic kidney disease or end stage renal disease * Participants with widespread, definitive leptomeningeal disease * Participants with a maximum tumor diameter exceeding 5 cm (if not resected) * Participants with \>6 definitive lesions consistent with brain metastases * Participants with inadequate mental capacity to complete quality of life questionnaires

Locations (1)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Neurologic Mortality

Clinical parameter to be assessed via review of study visits and medical records indicating cause of death (neurologic versus systemic progressive disease).

Time frame: 12 months

Secondary Outcomes

All-cause Mortality

Death from any cause cumulative incidence estimate assessed at 1 year and 2 year

Time frame: Until death or loss to follow up, up to 24 months

Quality of Life as Assessed by Patient Questionnaire

Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT)

Time frame: Until death or loss to follow up, up to 24 months

Neurocognitive Function: Verbal Learning and Memory

Hopkins Verbal Learning Test -Revised (HVLT-R). Scores are transformed into Z scores.

Time frame: 12 months

Neurocognitive Function: Visual Attention and Task Switching

Trail Making Test Part A and B (TMT). Scores are transformed into Z scores.

Time frame: 12 months

Neurocognitive Function: Verbal Fluency

Controlled Oral Word Association Test (COWAT). Scores are transformed into Z scores.

Time frame: 12 months

Neurocognitive Function: Cognitive Impairment

Mini Mental Status Examination (MMSE). Scored 0 to 30. Higher scores indicate better cognitive function

Time frame: 12 months

Ability to Complete Activities of Daily Living

Data from ClinicalTrials.gov

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